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FDA REQUIRING CERTIFIED COPY OF CHEMISTRY SECTION OF NDAs, ANDAs/AADAs

Executive Summary

FDA REQUIRING CERTIFIED COPY OF CHEMISTRY SECTION OF NDAs, ANDAs/AADAs and relevant amendments and supplements to be sent by applicants to their home FDA district offices for pre-approval inspection under a final rule published in the Sept. 8 Federal Register. The final rule, unlike the proposed rule published in January 1991, does not require the submission of a copy of the biopharmaceutics section or draft labeling to the district office. "This final rule has been significantly revised to reduce the amount of inflation that an applicant would submit for a preapproval inspection and to permit a U.S. applicant to send the information directly to the appropriate FDA district office," FDA said. Like the proposed rule, the final rule specifies that the chemistry section of applications should contain certain information about batches used to conduct bioavailability/bioequivalence and stability studies. This information should include: the batch production record; the specifications and test procedures for each component; the names and addresses of the sources of the container and closure system; the names and addresses of contract facilities used, along with the operation performed by the contract firm; and the component and drug product test results. In response to the comments received on the proposed rule, FDA points out that the submission requirements apply only to the "pivotal" bioavailability/bioequivalence and "primary" stability studies. FDA also specifies that only the names and addresses of sources of the active and noncompendial inactive components of the drug product need to be identified. A proposed or actual master production record for manufacture of commercial lots will be required for ANDAs. However, the final rule was modified to allow an NDA applicant to provide instead a detailed description of the production process for a representative batch of its proposed product. The final rule requires applicants to send to the home district office a copy of all supplements to the chemistry section of an NDA or ANDA except labeling supplements. Foreign applicants are directed to submit third copies of application sections and relevant supplements to FDA headquarters in Rockville, MD.
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